Time to development of new brain metastases in responding patient [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]

A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Official Title ICMJE

An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Brief Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed

Patients may or may not have symptoms related to their brain metastases

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

Exclusion Criteria:

Increasing corticosteroid dose during the 7 days prior to first dose of study drug

Leptomeningeal involvement

Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix

Concurrent administration of any anticancer therapies other than those administered in the study

Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy 2 weeks prior to first dose of study drug

Prior treatment with BRAF or MEK inhibitors

Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects